Quality Management for Healthcare Organisations

What is this standard?

Specifies management system requirements for quality in healthcare organisations, covering healthcare service management.

Who is it for?

Hospitals, clinics and healthcare service providers.

What triggers an assessment?

• A corporate quality framework is wanted for healthcare service management.
• Patient safety and service quality need to be measured.
• A corporate customer or insurer wants quality assurance.

What does it not replace?

• Medical device manufacturers, medical laboratories and clinical services are not the same record; ISO 15189 is an accreditation for laboratories.
• It does not substitute for a healthcare facility licence.